Accuracy of Needle Placement Into The Subacromial Space of The Shoulder

This study has been completed.
Sponsor:
Information provided by:
University of California, Davis
ClinicalTrials.gov Identifier:
NCT01330641
First received: April 5, 2011
Last updated: April 6, 2011
Last verified: April 2011
  Purpose

This study attempts to determine the most accurate route for injection of the subacromial bursa in patients with rotator cuff tendonitis. Typically, in medical practice, one of the routes of injection is used. It has not been determined if one route is superior, or if all routes are equal in delivering medication into the subacromial bursa, which sits on top of the rotator cuff tendons.


Condition Intervention
Rotator Cuff Tendonitis
Procedure: Injection of Subacromial Bursa

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Accuracy of Needle Placement Into The Subacromial Space of The Shoulder

Further study details as provided by University of California, Davis:

Primary Outcome Measures:
  • Radiographic e Radiographic Evidence of Successful Subacromial Injection [ Time Frame: One-hour post injection ] [ Designated as safety issue: No ]
    After injection of the subacromial bursa, all patients had two view radiographs performed within one hour to assess the accuracy of the injections


Enrollment: 75
Study Start Date: September 2008
Study Completion Date: March 2011
Primary Completion Date: May 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Anterior injection Route
Group of patients injected with medication using the anterior route
Procedure: Injection of Subacromial Bursa
Injection of steroid and anesthetic to relieve pain
Active Comparator: Posterior Injection
Group of patients receiving injection through a posterior route
Procedure: Injection of Subacromial Bursa
Injection of steroid and anesthetic to relieve pain
Active Comparator: Lateral Injection
Group of patients receiving subacromial injection through a lateral route
Procedure: Injection of Subacromial Bursa
Injection of steroid and anesthetic to relieve pain

Detailed Description:

Patients with a diagnosis of rotator cuff tendonitis, having failed other non-operative measures, are offered an injection of steroid and local anesthetic to relieve their pain. This is standard treatment. In this study, patients are prospectively randomized to receive their injection by one of the three commonly used routes: anterior, posterior, or lateral. Accuracy of the injection is determined by including a small amount of contrast dye in the injection which will make the injection visible on post-injection radiographs.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • rotator cuff tendinitis

Exclusion Criteria:

  • diabetes
  • allergy to contrast dye
  • renal disease
  • pregnancy
  • frozen shoulder
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01330641

Locations
United States, California
University of California, Davis Department of Orthopaedic Surgery
Sacramento, California, United States, 95817
Sponsors and Collaborators
University of California, Davis
Investigators
Principal Investigator: Richard A Marder, MD University of California, Davis
  More Information

No publications provided

Responsible Party: Richard A. Marder MD, University of California, Davis
ClinicalTrials.gov Identifier: NCT01330641     History of Changes
Other Study ID Numbers: 200816140
Study First Received: April 5, 2011
Last Updated: April 6, 2011
Health Authority: United States: Institutional Review Board

Keywords provided by University of California, Davis:
Tendonitis
Rotator Cuff
Shoulder
Injection

Additional relevant MeSH terms:
Tendinopathy
Muscular Diseases
Musculoskeletal Diseases
Tendon Injuries
Wounds and Injuries

ClinicalTrials.gov processed this record on August 21, 2014